Endoscope tip attachment device

ABSTRACT

Embodiments of the disclosure include an endoscope tip assembly for use on an endoscope, during procedures. The endoscope tip assembly may include a base, configured to receive an endoscope tip configured to not disengage from the endoscope tip during a procedure. The endoscope tip assembly may also include a plurality of struts, connected by a webbing, that may fold flat during insertion, and may assume a balloon-like shape during withdrawal.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/245,711, filed on Oct. 23, 2015.

TECHNICAL FIELD

Embodiments of the present disclosure relate to an endoscope accessoryand, more particularly, to an endoscope tip assembly for supporting thedistal tip of an endoscope and/or for improving field of view of anendoscope during use.

BACKGROUND INFORMATION

In endoscopic procedures, endoscopes are inserted through an orifice orincision and through the body lumen. The endoscope may be guided throughinternal body lumens, e.g., the gastrointestinal tract, to a region ofinterest, such as the stomach, cecum, duodenum, small intestine, largeintestine, or esophagus. The instruments are provided with afiber-optic, charge-couple device (CCD), or a CMOS camera, which enableimages to be transmitted along the flexible endoscopes and reproduced ona display external to the body of the patient. Accordingly, it ispossible to view the internal surfaces of body lumens during theseprocedures. For example, a gastroscope may be used to view the internalsurfaces of the esophagus, stomach, or duodenum.

Endoscopic procedures may be used to provide visual diagnosis (e.g., ofan ulceration or polyp), treatment, biopsy, and/or removal of tissue.While colonoscopic and enteroscopic examinations may be effectivetechniques to assess the state of health of an internal body region,they may cause complications and, in some instances, may fail to allow aclinician to accurately visualize a region of interest. For example, aclinician may not be able to complete the procedure, may fail to detecta polyp, lesion, or other structure, or may cause injury to the bodylumen in which the endoscope is inserted, e.g., via the application oftraumatic force, which may result in inflammation, burns, bleeding,scarring, perforation, or other injury.

Endoscopic procedures may be time consuming for patients and medicalpersonnel alike, depending upon how difficult it is to advance a scopethrough the body lumen or to view the surrounding region. Increasedprocedure times require a patient to be sedated for longer periods, mayincrease patient discomfort, and thus may increase recovery time.Additionally, there is an in-hospital recovery period, which may lastseveral hours while the anesthesia wears off, and, during that time,clinical observation is needed. Increased procedure time further cutsdown on the number of procedures that a given team of clinicians canperform in one day and limits the use of an operating room.

Anatomical and technological limitations may also contribute to thedifficulties of these procedures. First, the anatomy of a body lumen,e.g., the colon, may be tortious, and the lining may be uneven. Forexample, the colon is arranged into a series of folds. As the tip of theendoscope passes along the lumen of the colon, these folds may hamperthe clinician's ability to visualize the entire surface of the mucosaand, in particular, to detect pre-malignant and malignant lesions andpolyps located along these folds. For example, during endoscopewithdrawal, lesions located on the distal faces of these folds may notbe visualized.

Second, the tip position of the endoscope may be difficult to maintainonce a lesion or polyp is detected and/or during a therapeutic,diagnostic, or biopsy procedure. Due to gravity, the endoscope tip maynot stay centered within the colon and may instead fall against the wallof the colon. As a colonoscope is inserted or withdrawn, the tip mayslide and drop inconsistently along the colon as it moves over thefolds. This movement and/or the effect of gravity may cause theclinician to become disoriented, lose visualization, or losepositioning. If tip position is lost, time must be taken to againrelocate the region of interest.

Additionally, the tortious nature of the gastrointestinal tract may makeit difficult for a clinician to navigate the endoscope to the region ofinterest. The turns of the bowel, folded surface of the colon, andeffects of gravity may cause the endoscope to bump and press on the bodylumen as the endoscope is advanced or withdrawn. This may lead tostretching of the bowel, perforation, bleeding, trauma to the mucosa,inflammation, or other injury. As a result, the patient may experiencepain, the patient's recovery time may increase, procedure time mayincrease, or the procedure may even need to be aborted prematurely.

A number of products have attempted to address the challenges associatedwith endoscopic procedures. For example, active balloon endoscopes andballoon attachments have been developed. The balloons are inflated onceinserted into the colon to assist with withdrawal and visualization.However, these devices may be complex to manufacture and use due to theneed for inflation and deflation mechanisms and the delicateness of theexpanding portions. Additionally, active balloons that form a permanentpart of an endoscope make scope-reprocessing (e.g., high level cleaningand disinfection) more challenging.

Other distal endoscope attachments that have rows of protrusions havebeen developed to aid in opening up colonic folds. However, theprotrusions of those devices typically provide very similar stiffnessand resistance to force in the direction of insertion and the directionof withdrawal. However, when inserting an endoscope, it is desirable tohave reduced resistance on the distal tip. Since insertion involves twomotions, linear advance and torqueing, the resistance to both of thosemotions should be low. Upon withdrawal, a device should engage with thecolon to open the folds. This means that protrusions should be compliantand have low flexing and torqueing stiffness upon insertion, and shouldbe configured to interact and engage with the colon and have relativelyhigher flexing stiffness upon withdrawal. If the protrusions are stiffupon insertion, this may cause increased insertion resistance, whichthen might cause the scope to loop and stretch the colon walls. Thismight produce mucosal trauma as the endoscope is inserted or withdrawn.Additionally, the force applied by the tips of the protrusions todiscrete surface areas of the wall of the body lumen may increasemucosal trauma or cause perforation. On the other hand, if theprotrusions are not stiff on withdrawal, they may not be capable to openthe colonic folds and may not help with visualization of the regionsadjacent the folds, as intended.

Accordingly, an improved endoscope attachment device is needed that ismore compliant upon insertion and has a higher resistance to force uponwithdrawal. Such a device may be capable of safely and effectivelyreducing the time taken for a clinician to perform an endoscopicprocedure and for increasing the effectiveness of the procedure.

The device of the present disclosure aims to overcome the limitations ofthe prior art by facilitating one or more of the following: lowresistance in an insertion direction; more effective opening of folds onwithdrawal, steadying and/or centering the endoscope tip's positionduring a medical procedure; reducing the potential for mucosal trauma;and/or providing better physical and/or visual access around colonicfolds.

SUMMARY OF THE EMBODIMENTS

Embodiments of the present disclosure relate to an endoscope tipassembly. Various embodiments of the disclosure may include one or moreof the following aspects.

In accordance with one embodiment, an endoscope tip assembly, mayinclude: a ring-shaped base having a substantially cylindrical innersurface that is dimensioned to receive a distal end of an endoscope; anda collapsible umbrella extending radially out from the base, wherein thecollapsible portion includes: a webbing forming a collapsible surface;and a plurality of flexible struts extending along the webbing andconfigured to flex to transition the collapsible umbrella between aninsertion state and a withdrawal state; wherein the flexible struts areeach attached to the inner surface of the base and extend from the innersurface, around an edge of the base, and radiate away from an outersurface of the base; and wherein, in the insertion state, the pluralityof struts are flexed toward a direction extending substantially parallelwith the outer surface of the base, and wherein, in the withdrawalstate, the plurality of struts are flexed outward away from the outersurface of the base and the tip of each of the plurality of struts ispointed in a distal direction substantially parallel to the outersurface of the base.

Various embodiments of the endoscope tip assembly may include: a tipassembly wherein a force required to flex the plurality of struts totransition the collapsible portion to the insertion state is less than aforce required to flex the plurality of struts to transition thecollapsible portion to the withdrawal state; a tip of each of theplurality of struts is off-axis from an intermediate portion of each ofthe plurality of struts; at least one of the plurality of strutsincludes one or more notches located along a distal-facing surface ofthe strut; and a base that is substantially rigid.

Various embodiments of the endoscope tip assembly may include: an innersurface of a base including at least one crush rib projecting from theinner surface; webbing that is pleated; an outer surface of the basethat includes at least one gripping structure; and an outer surface ofthe base that includes at least one self-locking window.

Various embodiments of the endoscope tip assembly may include: a baseincluding a shaft sleeve, a sleeve lock, and a strut support ring; and abase including a distal cap and a shaft sleeve.

Additional objects and advantages of the embodiments will be set forthin part in the description that follows, and in part will be obviousfrom the description or may be learned by practice of the embodiments.The objects and advantages of the embodiments will be realized andattained by means of the elements and combinations particularly pointedout in the appended claims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate the disclosed embodiments and,together with the description, serve to explain the principles of thedisclosed embodiments. In the drawings:

FIG. 1 illustrates an exemplary endoscope tip assembly, with pleatedwebbing, according to an embodiment of the present disclosure;

FIG. 2 illustrates an exemplary endoscope tip assembly, according to anembodiment of the disclosure;

FIG. 3 illustrates an exemplary endoscope tip assembly, with the webbingremoved for clarity, according to an embodiment of the disclosure;

FIG. 4 illustrates an exemplary endoscope tip assembly, with the webbingremoved for clarity, according to an embodiment of the disclosure;

FIG. 5 illustrates an exemplary endoscope for receiving an endoscope tipassembly;

FIG. 6 illustrates an exemplary endoscope tip assembly mounted on anendoscope in a resting position, according to an embodiment of thedisclosure;

FIG. 7A illustrates an exemplary endoscope tip assembly mounted on anendoscope in an insertion position, according to an embodiment of thedisclosure;

FIG. 7B illustrates an exemplary endoscope tip assembly mounted on anendoscope in a withdrawal state, according to an embodiment of thedisclosure;

FIG. 8 illustrates an exemplary endoscope tip assembly mounted on anendoscope in a withdrawal position, according to an embodiment of thedisclosure;

FIG. 9A illustrates an exemplary endoscope tip assembly mounted on anendoscope in a withdrawal position inside of a colon, according to anembodiment of the disclosure;

FIG. 9B illustrates an endoscope, equipped with a balloon, inside of acolon;

FIG. 10 illustrates an exemplary endoscope tip assembly with struts inan insertion position and the webbing removed for clarity, according toan embodiment of the disclosure;

FIG. 11 illustrates an exemplary endoscope tip assembly with strutsextended past the withdrawal position, and the webbing removed forclarity, according to an embodiment of the disclosure;

FIG. 12 illustrates a magnified view of a portion of an exemplaryendoscope tip assembly with struts in a resting position, and thewebbing removed for clarity, according to an embodiment of thedisclosure;

FIG. 13 illustrates an exemplary endoscope tip assembly in a restingposition, with the webbing removed for clarity, according to anembodiment of the disclosure;

FIG. 14 illustrates an exemplary strut for an endoscope tip assembly,according to an embodiment of the disclosure;

FIG. 15 illustrates an exemplary strut for an endoscope tip assembly,according to an embodiment of the disclosure;

FIG. 16 illustrates an exemplary endoscope tip assembly, with thewebbing removed for clarity, according to an embodiment of thedisclosure;

FIG. 17A illustrates an exemplary endoscope tip assembly mounted on anendoscope in a resting position, according to an embodiment of thedisclosure;

FIG. 17B illustrates a partial cross-section view of an exemplaryendoscope tip assembly mounted on an endoscope in a resting position,according to an embodiment of the disclosure;

FIG. 18A illustrates an exemplary endoscope tip assembly mounted on anendoscope in a resting position, according to an embodiment of thedisclosure;

FIG. 18B illustrates a partial cross-section view of an exemplaryendoscope tip assembly mounted on an endoscope in a resting position,according to an embodiment of the disclosure;

FIG. 19A illustrates an exemplary endoscope tip assembly in a restingposition, according to an embodiment of the disclosure;

FIG. 19B illustrates an exemplary endoscope tip assembly mounted on anendoscope in a resting position, according to an embodiment of thedisclosure;

FIG. 20A illustrates an exemplary endoscope tip assembly in a restingposition, according to an embodiment of the disclosure;

FIG. 20B illustrates an exemplary endoscope tip assembly in a restingposition, according to an embodiment of the disclosure;

FIG. 21A illustrates a cross-section view of a strut in an insertionposition, according to an embodiment of the disclosure;

FIG. 21B illustrates a cross-section view of a strut in a restingposition, according to an embodiment of the disclosure;

FIG. 21C illustrates a cross-section view of a strut in a withdrawalposition, according to an embodiment of the disclosure;

FIG. 22 illustrates an exemplary endoscope tip assembly, with pleatedwebbing that does not extend to the end of the strut, according to anembodiment of the present disclosure;

FIG. 23 illustrates an exemplary endoscope tip assembly, with pleatedwebbing that does not extend to the end of the strut, according to anembodiment of the present disclosure;

FIG. 24 illustrates an exemplary endoscope tip assembly mounted on anendoscope in a resting position, according to an embodiment of thedisclosure;

FIG. 25A illustrates an exemplary endoscope tip assembly mounted on anendoscope in a resting position, according to an embodiment of thedisclosure; and

FIG. 25B illustrates an exemplary endoscope tip assembly mounted on anendoscope in a resting position, according to an embodiment of thedisclosure.

DETAILED DESCRIPTION

Reference will now be made in detail to the exemplary embodiments of thepresent disclosure described below and illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to same or like parts.

For purposes of this disclosure, an “endoscope” may refer to anysuitable type of scope for insertion into a patient during a medicalprocedure. Endoscopes may include, for example, colonoscopes,duodenoscopes, gastroscopes, sigmoidoscopes, enteroscopes,ureteroscopes, and bronchoscopes. The term “procedure” broadly refers tothe insertion of an endoscope into a patient for any purpose, including,but not limited to, surgery, biopsy, diagnosis, treatment,visualization, implantation or removal of a device, suction, orinsufflation.

Prior to providing a detailed description, the following overviewgenerally describes the contemplated embodiments. Endoscope tip assembly17 of the current disclosure is configured to attach to a distal end ofan endoscope and to assume a streamline profile upon insertion of theendoscope within a body lumen and to assume an expanded configurationupon withdrawal of the endoscope to enlarge the body lumen to facilitateinspection of a region of interest.

Endoscope tip assembly 17 includes an attachment base 4. Base 4 isconfigured to receive a distal end of an endoscope so that an innersurface of base 4 attaches to an outer tip of the endoscope.Accordingly, base 4 may be sized so that the inner diameter is slightlylarger than the diameter of the endoscope tip and has a complimentaryshape. Specifically, base 4 is configured to be received on a rigid tipof an endoscope, as discussed further below, and may be slid, twisted,or friction-fit into place. The outside surface of the base may serve asa support for the bottom surface of the struts on withdrawal, asexplained further below.

Base 4 may be present as a single unit attached to struts 3 and webbing2, as discussed below. Base 4 may include separate parts, for exampleshaft sleeve 22 and sleeve lock 23, discussed below. Alternatively, base4 may include shaft sleeve 30 and sleeve lock 25. In another embodiment,base 4 may include shaft sleeve 27, sleeve lock 26, and strut supportring 28. In a further embodiment, base 4 may include shaft sleeve 27 anddistal cap 29. In the aforementioned embodiments, the components workcooperatively to provide support to struts 3 and webbing 2 and to firmlygrip the tip of the endoscope, to prevent endoscope tip assembly fromdislodging during a procedure.

Base 4 may include a plurality of gripping windows 19 or a plurality ofpressure pads 24. Upon withdrawal, struts 3 may bear or press ongripping windows 19 or pressure pads 24. As struts 3 apply pressure toeither gripping windows 19 or pressure pads 24, that force may increasethe sliding friction between either gripping windows 19 or pressure pads24 and the outer surface of the rigid tip of an endoscope. Thisself-locking action leading to increased friction may aid in preventingendoscope tip assembly 17 from disengaging from an endoscope during aprocedure.

Webbing 2 with thickened struts 3 cooperatively define a collapsibleumbrella portion extending out from base 4. Struts 3 may extend frombase 4 and may be configured to flex relative to base 4 in order toassume a more streamlined, collapsed profile upon insertion into a bodylumen and an enlarged, expanded profile upon withdrawal. In thecollapsed configuration, struts 3 may be configured to fold so that theyare substantially parallel with an axis of the endoscope to whichendoscope tip assembly 17 is attached. In the expanded configuration,struts 3 may be configured to extend away from the endoscope's axis andtowards the periphery of the body lumen in order to gently push on thebody lumen into which the endoscope is inserted. Accordingly, whenexpanded, struts 3 may apply pressure to the circumference of the bodylumen in order to enlarge the body lumen in the region surroundingendoscope tip assembly 17.

Struts 3 extend along webbing 2, forming a surface that connects struts3 with one another, similar in manner to how the material of an umbrellaextends between the ribs of an umbrella. Webbing 2 may extend along allor along a portion of the length of struts 3. Webbing 2 may extend allthe way down the length of struts 3 to connect with base 4; webbing 2may lie flush with the tips of struts 3; webbing 2 may cover only aportion of the struts leaving a length 31 between the tips of struts 3and the distal edge of webbing 2; or may extend beyond the tips ofstruts 3.

By extending between the tips of struts 3 and connecting struts 3 withone another, webbing 2 distributes the force applied to the body lumenby struts 3 more evenly across a larger surface area when in theexpanded configuration. Instead of struts 3 applying elevated pressureto the body lumen, which may cause trauma to the lumen, webbing 2 andstruts 3 cooperatively create a continuous contact surface over whichthe force of expanded struts 3 is distributed along the periphery of thebody lumen. Accordingly, instead of resulting in a few high-pressurecontact regions centralized around the contact area of struts 3, thedisclosed device creates a larger, diffuse, lower-pressure contactregion similar to that of some balloon devices. For example, thecombined calculated area of the eight struts 3 in the depictedembodiment may be approximately 480 mm², and the calculated total areaof webbing 2 may be approximately 1670 mm². However, passive endoscopetip assembly 17 lacks the technical limitations and difficulties of suchactive balloon devices. Exemplary embodiments and details of endoscopetip assembly 17 are described further below.

Reference is now made to FIG. 1, which illustrates an exemplaryendoscope tip assembly 17, in a resting state, in accordance with anembodiment of the disclosure. Endoscope tip assembly 17 includes base 4.As discussed above, base 4 may be configured to fit onto and attach to adistal end of an endoscope. Base 4 is designed to prevent endoscope tipassembly 17 from detaching from an endoscope when maneuvered within abody lumen during use. To this end, base 4 may include texturing,protrusions, and/or pressure points, for example, to increase frictionbetween an inner surface of base 4 and an outer surface of the endoscopetip.

As shown in FIG. 1, an exemplary endoscope tip assembly 17 may includeone or more crush ribs 11. Crush ribs 11 may protrude from the innersurface of base 4 to contact the endoscope and may increase contactpressure between base 4 and the endoscope tip, thereby increasingsliding friction to prevent endoscope tip assembly 17 from disengagingfrom the endoscope during a procedure. Crush ribs 11 may extend along anaxis of base 4 or may extend at an angle to or perpendicular to theaxis. Crush ribs 11 may include a plurality of discrete ribs or mayextend from one end of base 4 to the other or around the fullcircumference of base 4. In some embodiments, crush ribs 11 may form acircular or screw-like design around the circumference of base 4. Insome embodiments, crush ribs 11 may be parallel to one another, at anangle to one another, or in any suitable arrangement to increasefriction. Crush ribs 11 may taper at one end, e.g., the proximal end,into a funnel or conical shape, which may facilitate engagement with therigid distal portion of the endoscope to which it is attached. Further,crush ribs 11 may be solid or hollow or may have both solid and hollowregions.

Crush ribs 11 may be configured to deform slightly upon engagement withthe endoscope or when pressure is applied to endoscope tip assembly 17during removal of the device from the endoscope or during withdrawal ofthe endoscope in the body. Crush ribs 11 may be formed of any suitablematerial, discussed below. Crush ribs 11 may protrude from an innersurface of base 4 a suitable amount, for example, ranging from about 0.2mm to about 0.7 mm. The inner diameter including crush ribs 11 may besmaller than the outer diameter of the scope, discussed below. The innerdiameter including crush ribs 11 of endoscope tip assembly 17 mayaccordingly range from about 12.75 mm to about 15 mm for an adultdevice, and from about 8.75 mm to about 12 mm for a pediatric device,depending on the durometer of the material(s) that base 4 and crush ribs11 are made of. Without crush ribs 11, base 4 may have a diameterranging from about 12.25 mm to about 15 mm for an adult device, and fromabout 8.25 mm to about 12 mm for a pediatric device. The inner diameterof base 4 may be the same diameter as the surface upon which crush ribs11 are attached, such that the two surfaces are flush. In anotherembodiment, the inner diameter of base 4 may be a different diameterthan the diameter of the surface upon which crush ribs 11 are attached.Exemplary material(s) that may be used to form base 4 and crush ribs 11include thermoplastic elastomers (e.g., polyurethane or santoprene),thermosets (e.g., rubber and silicone rubber), or any other suitablematerial. The hardness durometer of the material(s) that base 4 andcrush ribs 11 are formed of may range from about 20 A to about 70 A.

Alternatively, an inner surface of base 4 may be substantially smooth ormay include a textured pattern that extends across the inner surface ofbase 4 and may not include crush ribs 11. For example, the inner surfacemay include a coating or texturing that maintains the placement ofendoscope tip assembly 17 on an endoscope. In some embodiments, base 4and/or an inner surface of base 4 may be formed of a material with ahigher coefficient of friction. Or, in some embodiments, the smooth ortextured surface may further include one or more crush ribs 11.

An outer surface of base 4 may include one or more ridges, protrusions,indents, and/or textures to assist a clinician with attaching andremoving endoscope tip assembly 17 from an endoscope. For example, as isshown in FIG. 1, base 4 may include one or more dimples 12 locatedaround the outer perimeter of base 4. Dimples 12 may aid the clinicianin gripping base 4 when endoscope tip assembly 17 is installed onto orremoved from an endoscope.

The overall size and shape of base 4 may be based on the size and shapeof the distal end of the endoscope on which tip assembly 17 isconfigured to attach. Exemplary endoscopes may range in diameter fromapproximately 13 mm to about 15 mm for adult endoscopes, while apediatric endoscope may have a tip diameter ranging from about 9 mm toabout 12 mm. In some embodiments, the inner diameter of base 4 may bebetween about 10 mm and about 14 mm. Further, the outer diameter of base4 may be configured to protrude only slightly from the surface of theendoscope onto which it fits so as to not substantially increase thediameter of the endoscope tip in order to facilitate insertion when theendoscope tip assembly 17 is in the collapsed, insertion configuration.For example, the outer diameter of base 4 may be about 11 mm to about 17mm. In some embodiments, base 4 of endoscope assembly 17 may come in avariety of sizes, for example, depending on the size and/or type ofendoscope that the device is intended for use with.

Base 4 may be dimensioned so that when mounted on an endoscope,endoscope tip assembly 17 engages only a distal-most portion of theendoscope. The distal-most ends of many endoscopes include a rigidcylindrical tip, which may be made of rigid plastic or metal, to definethe end of the endoscope, provide rigidity, and/or to encase or protectthe optics and other structures located on the distal face of theendoscope. The bending portion of the endoscope is generally locatedproximal to this distal metal ring. The bending portion of mostendoscopes is more flexible and is generally made of more delicatematerials. It may thus be easier to puncture or damage this bendingportion, which may cause leakage or may otherwise damage or compromisethe integrity of the endoscope. Given the expense of endoscopes, thiswould be undesirable and, if the damage occurs during use, this mayinterrupt or render the ongoing procedure impossible.

Accordingly, it may not be desirable to slide an endoscope accessoryover the bending portion or otherwise affix a device directly to thebending portion of an endoscope, either on a regular or occasionalbasis. To ameliorate this problem, endoscope tip assembly 17 is designedto interact with the rigid tips of endoscopes rather than themore-delicate bending portions. Thus, base 4 may be dimensioned so as tofit on the rigid-tip portion of an endoscope without overlapping ontothe bending portion. Additionally, because endoscope tip assembly 17sits at the distal tip of an endoscope, this may provide bettervisibility since the body lumen may be expanded at a region closer tothe distal face of the endoscope where the optics are located.

Yet other devices typically are designed to affix to the bending portionin order to prevent them from disengaging from the endoscope during use.It was generally thought that an endoscope accessory should interactwith and affix to more than simply the tip of an endoscope in order tokeep the accessory in place. While other devices may be configured forplacement further back on endoscopes or may assume a wider dimension toincrease the contact area with the endoscope to resist detachment duringuse, embodiments of the disclosed device may be more narrow andconfigured to contact the distal, rigid ridge predominantly orexclusively while remaining in place on the endoscope. This may beachieved via, e.g., the use of crush ribs 11 and/or other designs, aswill be discussed further below. In some embodiments, the intendedplacement of endoscope tip assembly 17 on only the rigid portion of theendoscope may allow for the provision of a tighter friction-fit becausethe design does not need to account for the delicateness of the bendingportion. This may also allow base 4 to be more rigid. The rigidity ofbase 4 may also aid with removal by allowing a clinician to grip andapply pressure to the assembly without also applying pressure to theunderlying endoscope and increasing friction between endoscope tipassembly 17 and the endoscope.

Endoscope tip assembly 17 includes a collapsible umbrella extendingradially out from base 4. The umbrella is formed of webbing 2 and aplurality of flexible struts 3 configured to flex to transition thecollapsible umbrella between the insertion, resting, and withdrawalstates.

Endoscope tip 17 assembly may include anywhere from about one to abouttwenty struts 3 attached to base 4. For example, there may be three,four, five, six, eight, or twelve struts 3 attached to base 4. Struts 3are flexible and are configured to flex between a resting position, aninsertion position, and a withdrawal position. In the insertionposition, shown in FIG. 7A, struts 3 are configured to flex in aproximal direction along the axis of the endoscope. This results in astreamlined profile for facilitating insertion of the endoscope into thebody. Once inserted into a body lumen and guided to a region ofinterest, the endoscope may be slowly withdrawn to visualize the regionof interest. As the endoscope is withdrawn, struts 3 may engage the bodylumen and flex out from the axis of the endoscope. As the endoscope isfurther withdrawn, struts 3 may bend until the tips of struts 3 point ina distal direction, as shown in FIG. 8. This is the withdrawal position.When not in use, endoscope tip assembly 17 may assume a restingposition, as shown in FIG. 1, in which struts 3 are biased to flare outfrom the axis of the endoscope. The natural outward biasing of struts 3in the resting position may facilitate the transition between theinsertion and the withdrawal position inside the body lumen.

In some embodiments, when endoscope tip assembly 17 is in a restingposition, the total strut span may range from about 30 mm to about 70mm. When endoscope tip assembly 17 is in the insertion position, thetotal strut span may range from about 12 mm to about 18 mm. Theaforementioned strut span ranges may vary depending upon the procedureand the patient. For example, the average diameter of the uppergastrointestinal tract lumen may be different from the average diameterof the lumen of the lower gastrointestinal tract or of other bodylumens. Additionally, the average diameter of the same body lumens in aninfant or youth may be different than that of an adult. Accordingly, thestrut span may reflect the intended application, or even the particularpatient, as appropriate sizing of the strut span will facilitateeffective engagement with the lumen without applying an undesirableamount of pressure to the lumen.

Struts 3 support webbing 2 to transition webbing 2 between a collapsedinsertion state (similar in profile to a collapsed umbrella) and aflipped, withdrawal state (similar in profile to an inside-outumbrella). As previously described, webbing 2 and struts 3 workcooperatively to create a diffuse, high-surface-area, low-pressureregion of contact with the body lumen when in the withdrawal state,similar in manner to how a balloon would apply pressure to a lumen. Forexample, reference is made to FIG. 9A. The portion of endoscope tipassembly 17 that contacts the body lumen is spread out over a greatersurface area created by webbing 2 and struts 3, as opposed to, forexample, the surface of struts 3 alone. The diffuse contact region inFIG. 9A created by endoscope tip assembly 17 is similar to the diffusecontact region created by an endoscope equipped with a balloon.

In one embodiment, when in a resting position, there may be slack inwebbing 2 between adjacent struts 3, as shown in FIG. 1, or as is shownin FIG. 2, there may be substantially no slack between adjacent struts3. Webbing 2 may have a pleated pattern 1, as illustrated in FIG. 1, ormay have a non-pleated pattern, as illustrated in FIG. 2. In either thepleated or non-pleated embodiment, webbing 2 may extend flush with theends of struts 3, as shown in FIGS. 1 and 2, or may extend past the endsof struts 3. In some embodiments, webbing 2 may extend flush with struts3 where it joins the ends of struts 3 but extend beyond them in a regionbetween struts 3, or vice versa.

In one embodiment, webbing 2 and struts 3 of the collapsible umbrellamay be formed of different materials. For example, webbing 2 and struts3 may be attached to each other by an adhesive. In some embodiments, theadhesive may be an RTV (Room Temperature Vulcanizing) adhesive. Inanother embodiment, webbing 2 and struts 3 may be attached to each otherby plastic or radio-frequency welding. In a further embodiment, webbing2 and struts 3 may be uniformly molded. In one embodiment, webbing 2 mayrange from about 0.05 mm to about 0.2 mm in thickness.

In some embodiments, a gap 21 may be present in embodiments in whichwebbing 2 does not extend down struts 3 to meet with base 4. This gap 21may allow fluids and gases to pass through when endoscope tip assembly17 is in the withdrawal position when struts 3 and webbing 2 are engagedwith the lumen. In other embodiments, gap 21 may be absent. In someembodiments, the distance between base 4 and the distal edge of webbing2 may be between about 1 mm and about 6 mm.

In some embodiments, base 4 may include a plurality of dimples 12. Aspreviously mentioned, dimples 12 may facilitate gripping of endoscopetip assembly 17 by a clinician, which may aid in the installation ontoand removal from an endoscope. However, dimples 12 shown in FIG. 1 areexemplary. Any suitable design or pattern that aids a clinician ingripping endoscope tip assembly 17 is contemplated by this disclosure,such as, for example, ridges, grooves, or a textured finish or materialon an outer surface of base 4.

Webbing 2, struts 3, base 4, or crush ribs 11 may be made of the samematerial or different materials. Suitable materials include, thermosets(e.g., rubber or silicon rubber), thermoplastic elastomers (e.g.,thermoplastic polyurethane or santoprene, or other suitablebiocompatible materials. Webbing 2 may also be made of thermoplasticpolyurethane film, any suitable polymer, or any suitable biocompatiblematerials. One or more of webbing 2, struts 3, base 4, or crush ribs 11may also include a suitable coating, e.g., a lubricious oranti-bacterial coating.

Reference is now made to FIG. 3 and FIG. 4, which illustrate distal andproximal views, respectively, of endoscope tip assembly 17, drawnwithout webbing 2 for clarity, according to another embodiment of thedisclosure. In these views, the inner surface of an exemplary base 4 canbe viewed more clearly. As shown, struts 3 are attached to base 4 at aninner surface of base 4. Struts 3 extend from the inner surface of base4, over an edge of base 4, and flare outwards from base 4 to their tips.Struts 3 may be more flexible than base 4, which, in some embodiments,may be rigid. The attachment of struts 3 to base 4 will be described indetail further below. As discussed previously and shown here in moredetail, crush ribs 11 may increase the sliding friction between therigid endoscope tip and endoscope tip assembly 17. Crush ribs 11 areexemplary; other means for increasing sliding friction are contemplated,as discussed above, including, for example, ridges, or texturing.

In some embodiments, the struts 3 may be more flexible than base 4,which may be rigid. In some embodiments, the struts may be made out ofsilicone and the base 4 may be made out of polycarbonate or polysulfone.These materials are of substantial rigidity, are of medical grade, arecapable of being injection molded, and have a high glass transitiontemperature to allow for quick curing of silicone struts during siliconeovermolding.

Crush ribs 11, if included, may extend along struts 3, between struts 3,or both. They may be separate from struts 3 and/or base 4, or may beformed as part of one or the other, or both, e.g., in the event that allthree are formed of one material. Further, as shown in FIG. 4, crushribs 11 may extend along a surface of struts 11 where the base of struts11 attach to and project out from the inner surface of base 4. In suchan embodiment, crush ribs 11 may form a funnel for easier engagementwith the scope tip. In some embodiments, crush ribs 11 may be made ofthe same material as base 4 and/or struts 3. In other embodiments, crushribs 11 are made of a different material than crush ribs 11 and/orstruts 3.

Reference is now made to FIG. 5, which illustrates a generic endoscopedevice 10. An endoscope control portion 6 may include the knobs anddials that a clinician uses to guide tip 9 in a patient throughcontrolled bending of bendable portion 7, found at the distal region ofan insertion tube 5. Insertion tube 5 is a long, flexible tube thatbends as endoscope 10 is inserted into a patient. Bendable portion 7 iscontrolled, remotely, by a clinician and bends to navigate the turns ofa lumen. Rigid tip 9, the distal-most portion of the endoscope 10,houses, e.g., a camera face 8. Rigid tip 9 is where endoscope tipassembly 17 of the present disclosure may be affixed. Endoscope tipassembly 17 of the present disclosure may not extend onto bendableportion 7, as extending onto said portion may interfere with theclinician's ability to control the bending of portion 7 or may harmbending portion 7, as described above.

Reference is now made to FIG. 6, which illustrates endoscope tipassembly 17 mounted on an endoscope 10, in a resting state, according toan embodiment of the disclosure. In this embodiment, the distal edge ofbase 4 is flush with a camera face 8 of endoscope 7. This position mayhelp to ensure that endoscope tip assembly 17 sits only on ring 9 andmay not interfere with the operation of bendable portion 7 of endoscope10, although, in some embodiments, base 4 may be set back slightly fromthe face of the endoscope. In some embodiments, the angle between struts3 and the longitudinal axis of endoscope 7 may be between about 45° andabout 90° in the resting state.

Reference is now made to FIG. 7A, which illustrates an endoscope tipassembly mounted on endoscope 10, in the insertion state. In someembodiments, the angle between struts 3 and a longitudinal axis ofendoscope 10 may be between about 0° and about 45°. It is advantageousfor struts 3 and webbing 2 to collapse into this position duringinsertion so that a smaller overall diameter is achieved for ease ofinsertion. The force to flex struts 3 and webbing 2 into the insertionposition may be less than the force required to flex struts 3 andwebbing 2 into the withdrawal position, as discussed below. Only aportion of the thickness of each strut 3 may need to be bent totransition the strut from the resting position into the insertionposition. This thickness may range from about 0.5 mm to about 1 mm. Onthe other hand, more of the thickness of each strut 3 or all of eachstrut 3 may need to be bent to invert struts 3 into the withdrawalposition. This thickness may range from about 1 mm to about 3 mm.

Reference is now made to FIG. 7B, which illustrates an endoscope tipassembly mounted on endoscope 10, in a withdrawal position. Whenendoscope tip assembly 17 is in such a position, there may be slack inwebbing 2 between struts 3, which results in a pleating or bunching ofwebbing 2, similar to the pleating and bunching of an umbrella in aclosed position, as illustrated in FIG. 7B. In another embodiment, thepleats may be pre-formed such that pleating is present when there is noslack in the webbing.

Reference is now made to FIG. 8, which illustrates endoscope tipassembly 17 mounted on endoscope 10, in the withdrawal state. In someembodiments, the angle between struts 3 and the longitudinal axis ofendoscope 7 may be between about 50° and about 180° in the withdrawalstate, measured along a straight line extending from the tips of struts3 to where they meet base 4. The diameter of the inside-out umbrellashape created by struts 3 and webbing 2 in this position may range fromabout 20 mm to about 30 mm.

Endoscope tip assembly 17 assumes this position upon withdrawal of theendoscope by flipping inside-out like an umbrella from the insertionposition (similar in shape to a closed umbrella) depicted in FIG. 7A.Struts 3 may engage the body lumen as endoscope 10 is initiallywithdrawn, and this engagement in combination with withdrawal causesstruts 3 to flex outwards away from the endoscope and into thewithdrawal state. The inside-out umbrella shape of endoscope tipassembly 17 may contact the lumen and gently apply outward pressure tothe lumen, thereby resulting in less traumatic contact with the lumen bymaking contact with a larger surface area across a more diffuse region,as opposed to discreet points of contact at the tips of struts 3. Thecontact achieved using endoscope tip assembly 17 may be similar inmanner to the type of contact that would be achieved using the balloonof a balloon-equipped endoscope.

Reference is now made to FIG. 9A, which illustrates an endoscope tipassembly 17 mounted on endoscope tip 9 (obscured from view), inside of acolon 16 in a withdrawal state. The inside-out umbrella shape may leadto less traumatic contact with the colonic wall, as the outward force isevenly distributed around the perimeter of webbing 2, similarly to aballoon-equipped endoscope. As shown in FIG. 9A, in the withdrawalposition endoscope tip assembly 17 applies a gentle pressure to thecolon, holding the colonic folds in a more open configuration, which mayimprove visualization. In this manner, the shape may assist inmaximizing the clinician's visualization by flattening the colonicfolds, thereby revealing surfaces that may otherwise be obscured bythese folds. This shape may also assist in stabilizing endoscope tip 8so that a clinician may visually inspect the interior of the colon orperform a procedure more easily. Additionally, by expanding outwardsevenly on all sides of the endoscope, struts 3 and webbing 2 may centerthe endoscope in a central region of the lumen, helping to at leastpartially counteract the force of gravity and counteract the propensityof the endoscope tip to drop along the wall of the colon or to dragalong the wall of the colon during withdrawal.

Reference is now made to FIG. 9B, which illustrates an endoscope tipballoon mounted on an endoscope, inside of colon 16. Reference is madeto the similarity in the diffuse contact region between the balloon andthe colonic wall in FIG. 9B compared with that achieved by endoscope tipassembly 17 in FIG. 9A. However, the active balloon in FIG. 9B requiresadditional equipment to inflate and control the balloon, whereas thepassive endoscope tip assembly 17 in FIG. 9A does not require suchadditional equipment or control. Also, passive endoscope tip assembly 19is located right at the distal tip of the endoscope, whereas the axialdistance from the endoscope tip to the active balloon is much larger,potentially reducing the impact that fold opening has on improvedvisualization behind folds.

Reference is now made to FIG. 10, which illustrates endoscope tipassembly 17 in an insertion state, with webbing 2 omitted for clarity,in accordance with an embodiment of the disclosure. The embodiment ofFIG. 10 depicts a plurality of gripping windows 19. Base 4 may includeany suitable number of gripping windows 19. For example, base 4 mayinclude zero, two, four, six, eight, ten, twelve, or more grippingwindows 19. In some embodiments, gripping windows 19 may providegripping assistance to a clinician as he or she mounts and dismountsendoscope tip assembly 17. Gripping windows 19 may be located anywhereon base 4 and may be made of the same, or different, material as base 4.

Reference is now made to FIG. 11, which illustrates endoscope tipassembly 17 in a position with struts 3 folded in an extreme withdrawalstate, with webbing 2 omitted for clarity, in accordance with anembodiment of the disclosure. In some embodiments, it may beadvantageous for endoscope tip assembly 17 to be able to assume thesmallest possible outer diameter when mounted on an endoscope duringwithdrawal, when viewed along the longitudinal axis of the endoscope. Aminimal outer diameter may be achieved by struts 3 folding toward, andpotentially past, the distal end of the endoscope. This configurationmay help prevent traumatic contact, for example, in a more narrow areaof a body lumen, e.g., upon final removal of the endoscope tip from theanus. Accordingly, in some embodiments, struts may be able to flex in adistal direction to a position substantially parallel with an axis ofthe endoscope.

The force required for struts 3 to assume an insertion position, asillustrated in FIG. 10, is less than the force required for struts 3 toassume a withdrawal position, as illustrated in FIG. 8 and FIG. 11. Inone embodiment, the force required for struts 3 to flex into theinsertion position, as illustrated in FIG. 10, may range from about 0.3lb to about 0.4 lb. In another embodiment, the force required for struts3 to assume the withdrawal position, as illustrated in FIG. 11, mayrange from about 2.6 lb to about 3.0 lb. The ratio of withdrawalstiffness to insertion stiffness of struts 3 may range from about 5 toabout 8.

Requiring a small insertion force to flex struts 3 into an insertionposition may help prevent mucosal trauma during the procedure. Duringinsertion, the endoscope tip is guided to a region of interest, and thusthe goal is to achieve a streamline profile with a smaller diameter tofacilitate navigation. Endoscope tip assembly 17 is thus configured tobe substantially parallel to an axis of the endoscope and is notintended to apply an outward pressure to the colon to enlarge the colonin the insertion position. By contrast, during withdrawal, endoscope tipassembly 17 extends away from the axis of the endoscope to applypressure to the colon to enlarge the colon and aid in visualization.Thus, in the withdrawal position, struts 3 must be able to resist theforce of the endoscope being withdrawn and the friction applied by thebody lumen as the endoscope is being withdrawn. While some flexibilityin the withdrawal position may be desirable to prevent trauma to themucosa during the procedure, if they are too flexible in the withdrawalposition, then struts 3 may flex completely distally, as shown in FIG.10, which would fail to open up the colon, may obstruct the clinician'svision, and/or may fail to stabilize the endoscope tip in the center ofthe colon. The fact that a larger force may be required for endoscopetip assembly 17 to flip like an inside-out umbrella from an insertionposition to a withdrawal position may allow struts 3 and webbing 2 tomaintain an umbrella-like shape upon withdrawal, thus helping to improvevisualization and tip stabilization. In some embodiments, a small ratioof insertion force to withdrawal force may be desirable.

Reference is now made to FIG. 12, which illustrates an enlarged sideview of a portion of endoscope tip assembly 17 in a resting state, withwebbing 2 omitted for clarity, in accordance with an embodiment of thedisclosure. A positive stop 13 may assist strut 3 in maintainingposition and shape upon withdrawal. Positive stop 13 may help struts 3and webbing 2 maintain the inside-out umbrella shape upon withdrawal, aspreviously described.

Reference is now made to FIG. 13, which illustrates a close-up distalview of an endoscope tip assembly in a resting state, with webbing 2omitted for clarity, in accordance with an embodiment of the disclosure.As previously discussed, crush ribs 11 may be included on the innersurface of base 4, and they may assist in increasing the amount ofsliding friction between base 4 and an endoscope, which may in turnprevent endoscope tip assembly 17 from slipping off of an endoscopeduring a procedure.

Reference is now made to FIG. 14, which illustrates a side-view of anexemplary strut 3, in accordance with an embodiment of the disclosure.Strut 3 may exist in a variety of shapes and thickness. In someembodiments, the thickness along the length of strut 3 may vary, asindicated by tip portion 20 in FIG. 14. In some embodiments, the widthof strut 3 may vary, e.g., as shown in FIG. 14, tip portion 20 may benarrower than a base-mount 14. This difference in thickness and/or widthmay give rise to differences in flexibility and thus, differences inforces required to flex different regions struts 3. Alternatively, thethickness and/or width may be consistent along strut 3.

In some embodiments, the thickness of the straight portion of strut 3may range from about 0.5 mm to about 3.0 mm. In some embodiments, thethickness of tip portion 20 of strut 3 may range from about 0.5 mm toabout 1.0 mm. In some embodiments. In some embodiments, the width ofstrut 3 may range from about 2 mm to about 5 mm, and struts 3 may have auniform width or may vary in width along their length.

In some embodiments, tip portion 20 of strut 3 may be angled outward. Inone embodiment, the angle of tip portion 20 of strut 3 may range fromabout 110° to about 160°. If tip portion 20 is angled, it may helpstruts 3 to engage with the lumen by catching on the surface of thelumen upon withdrawal. This increased engagement may assist struts 3 andwebbing 2 to flip inside-out like an umbrella and thus achieve thewithdrawal state. At least in part because the thickness of each struttip is relatively thin and the rigidity of each of the strut tip isrelatively low, endoscope assembly 17 is pliable and atraumatic whenengaging the lumen and when in the withdrawal state.

Struts 3 and webbing 2 are configured to make contact with thesurrounding body lumen during withdrawal, in an effort to stabilize thetip of the endoscope and to improve visualization. Additionally, struts3 must interact with the body lumen to transition from the insertionposition to the withdrawal position. Therefore, the length of struts 3is dictated, at least in part, by the diameter of the body lumen intowhich it will be inserted. In some embodiments, the length of struts 3from positive stop 13 to the outermost tip may range from about 10 mm toabout 25 mm.

Reference is now made to FIG. 15, which illustrates a side-view of strut3, in accordance with an embodiment of the disclosure. In thisembodiment, strut 3 includes one or more notches 15. Notches 15 may giverise to a difference in stiffness of strut 3 between a proximal-facingsurface and a distal-facing surface of strut 3. For example, the surfaceof strut 3 with notches 15 may require less force to bend inwards onitself than a surface of strut 3 without notches 15. In someembodiments, this difference between one surface of strut 3 and theother may allow strut 3 to preferentially bend in one direction over theother.

In some embodiments, there may be one or more notches 15 in strut 3. Insome embodiments, notches 15 may be located only on the straight portionof strut 3. In other embodiments, the notches may be located on both thestraight portion and angled portion 20 of strut 3. In other embodiments,there may be no notches 15, as illustrated in FIG. 14. Notches 15 mayhave any suitable shape, e.g., slits, rectangular, triangular, U-shaped,or tapered in cross-section. The gaps formed on the notched surfaceallow that surface to collapse in on itself and the shape of the notchesmay thus affect the flexibility of strut 3.

Reference is now made to FIG. 16, which illustrates an angled view ofthe distal end of endoscope tip assembly 17, with notches 15 in struts3, where webbing 2 has been omitted for clarity, in accordance with anembodiment of the disclosure. FIG. 16 illustrates that, when notches 15are present in struts 3, struts 3 assume a resting position similar tothat of struts 3 without notches, as illustrated in FIG. 3. Reference isnow made to FIG. 17A, which illustrates an endoscope tip assembly 17mounted on an endoscope 10 in a resting state, in accordance with anillustrative embodiment of the disclosure. Shaft sleeve 22 and sleevelock 23 may work cooperatively to prevent endoscope tip assembly 7 fromdisengaging from an endoscope and to provide support and rigidity tostruts 3 during withdrawal. Sleeve lock 23 may be tapered such that theinner diameter of the distal end may be slightly greater than the innerdiameter at the proximal end. In one embodiment, the distal end ofsleeve lock 23 may have a diameter ranging from about 13.8 mm to about15.5 mm. In another embodiment, the proximal end of sleeve lock 23 mayhave a diameter of about 12.8 mm to about 15.0 mm. Like sleeve lock 23,shaft sleeve 22 may also be tapered, with the outer diameter of theproximal end of shaft sleeve 22 being slightly larger than the diameterof the distal end. In one embodiment, the outer diameter of the distalend may range from about 13.3 mm to about 15.5 mm. In anotherembodiment, the outer diameter of the proximal end may range from about13.8 mm to about 16 mm. The tapered nature of both shaft sleeve 22 andsleeve lock 23 may aid in increasing sliding friction between shaftsleeve 22 and rigid tip 9 during withdrawal, when struts may be forcedto flex in a distal direction and press on sleeve lock 23. The taperedsections may engage, increasing the pressure and friction force betweenshaft sleeve 22 and rigid tip 9, which may prevent endoscope tipassembly 17 from disengaging from rigid tip 9.

Reference is now made to FIG. 17B, which illustrates a partialcross-section view of an exemplary endoscope tip assembly mounted on anendoscope in a resting position, according to an embodiment of thedisclosure. The cross-section view illustrates the difference inthickness between the proximal and distal ends of sleeve lock 23, andhow it makes contact with shaft sleeve 22. In one embodiment, shaftsleeve 22 and sleeve lock 23 may be made out of the same material. Inanother embodiment, shaft sleeve 22 and sleeve lock 23 may be made outof different materials. The width of sleeve lock 23 may range from about2 mm to about 10 mm.

Reference is now made to FIG. 18A, which illustrates an exemplaryendoscope tip assembly mounted on an endoscope in a resting position,according to an embodiment of the disclosure. In one embodiment aplurality of pressure pads 24 may be present. In some embodiments, theremay be from about 4 pressure pads 24 to about 12 pressure pads 24. Uponwithdrawal, struts 3 may press on and apply pressure to pressure pads24. As pressure is applied to pressure pads 24, the sliding frictionbetween base 4 and rigid tip 9 of endoscope 10 may increase, and thusmay prevent endoscope tip assembly 17 from falling off during aprocedure.

Reference is now made to FIG. 18B, which illustrates a partialcross-section view of an exemplary endoscope tip assembly mounted on anendoscope in a resting position, according to an embodiment of theinvention. This cross-section view illustrates the contact betweensleeve lock 25, pressure pad 24, and shaft sleeve 30. As previouslymentioned, during withdrawal, struts 3 may press against and applypressure to pressure pads 24, which may in turn increase pressurebetween shaft sleeve 30 and rigid tip 9 of endoscope 10. In oneembodiment, shaft sleeve 30 and sleeve lock 25 may be separate pieces.In another embodiment, shaft sleeve 30 and sleeve lock 25 may be onepiece. In one embodiment the length of each pressure pad 24 may rangefrom about 2 mm to about 7 mm. In another embodiment, the width of eachpressure pad 24 may range from about 2 mm to about 5 mm. In oneembodiment, shaft sleeve 30 and sleeve lock 25 may be made from the samematerial. In another embodiment, shaft sleeve 30 and sleeve lock 25 maybe made of different materials. Reference is now made to FIG. 19A, whichillustrates a partially exploded view of an exemplary endoscope tipassembly in a resting position, according to an embodiment of thedisclosure. In one embodiment, base 4 may contain shaft sleeve 27,sleeve lock 26, and strut support ring 28. These three pieces may workcooperatively to increase sliding friction between shaft sleeve 27 andrigid tip 9 of endoscope 10 to prevent endoscope tip assembly 17 fromfalling off during a procedure, and/or to provide a rigid surface uponwhich struts 3 may push during withdrawal. This arrangement may providefor a disengagement force that is greater than the force required tofriction fit endoscope tip assembly 17 onto an endoscope tip. In oneembodiment, the coefficient of friction between sleeve lock 26 and shaftsleeve 27 may be less than the coefficient of friction between shaftsleeve 27 and rigid tip 9. Sleeve lock 26 may include ribs 11, which mayserve to apply additional pressure on shaft sleeve 27, therebyincreasing sliding friction between shaft sleeve 27 and rigid tip 9 ofendoscope 10. In one embodiment, shaft sleeve 27, sleeve lock 26, andstrut support ring 28 may be made of the same material. In anotherembodiment, shaft sleeve 27, sleeve lock 26, and strut support ring 28may be made of different materials. Crush ribs 11 have properties aspreviously discussed.

The inner diameter of sleeve lock 26 is tapered, increasing toward theproximal end, and the taper angle may range from about 0.5° to about2.5°. The outer diameter of shaft sleeve 27 is also tapered in the samedirection, with a diameter of the distal end that is smaller than thediameter of the proximal end. The taper angle of shaft sleeve 27 mayvary from about 0.5° to about 2.5°. In one embodiment, the innerdiameter of the distal end of sleeve lock 26 may be identical to theouter diameter of the distal end of shaft sleeve 27. In anotherembodiment, the inner diameter of the distal end of sleeve lock 26 maybe slightly less than the outer diameter of the distal end of shaftsleeve 27. For example, in one embodiment, the inner diameter of sleevelock 26 may be from about 14 mm to about 16 mm for an adult colonoscope.In another embodiment, the outer diameter of shaft sleeve 27 may be fromabout 14 mm to about 15.5 mm. In one embodiment, the width of sleevelock 26 may be about the same as the width of shaft sleeve 27. Inanother embodiment, the width of sleeve lock 26 may be different fromthat of shaft sleeve 27. In one embodiment, the width of sleeve lock 26may be from about 5 mm to about 10 mm. In another embodiment, sleevelock 26 may have a thickness ranging from about 0.4 mm to about 1.5 mm.In another embodiment, shaft sleeve 27 may have a thickness from about0.3 mm to about 0.75 mm. In one embodiment, strut support ring 28 mayhave a thickness ranging from about 0.3 mm to about 1.0 mm.

Reference is now made to FIGS. 20A and 20B, which illustrate anexemplary endoscope tip assembly in a resting position, according to anembodiment of the disclosure. In one embodiment, base 4 may containdistal cap 29 and shaft sleeve 27. These two pieces may workcooperatively to increase sliding friction between shaft sleeve 27 andrigid tip 9 of endoscope 10 to prevent endoscope tip assembly 17 fromfalling off during a procedure, and/or to provide a rigid surface uponwhich struts 3 may push during withdrawal. Further, in extending pastthe end of endoscope 10, distal cap 29 may aid in holding back the lumensuch that camera 8 has an unobstructed view. The inner diameter ofdistal cap 29 may be about the same as the outer diameter of shaftsleeve 27. In another embodiment, the inner diameter of distal cap 29may be different than the outer diameter of shaft sleeve 27. In oneembodiment, the inner diameter of distal cap 29 may range from about 12mm to about 17 mm. In another embodiment, the outer diameter of shaftsleeve 27 may be from about 13 mm to about 15 mm. In one embodiment,such as, for example, FIG. 20A, the width of distal cap 29 may beconsistent along the circumference and may range from about 2 mm toabout 8 mm. In another embodiment, such as, for example, FIG. 20B, thewidth of the distal cap may vary. In some embodiments, the width ofdistal cap 29 may vary along the circumference of the cap, where thewidth may range from about 2 mm to about 12 mm.

Reference is now made to FIG. 21A, which illustrates a cross-sectionview of a strut in an insertion position, according to an embodiment ofthe disclosure. Base 4 is permanently adhered to strut 3, as indicatedby A, however it is not permanently adhered strut 3 at C. Duringinsertion, the insertion force, f_(insertion), needed to flex struts 3in a proximal direction may be low compared to the force required duringwithdrawal, F_(withdrawal), because the resistance, r_(insertion),attempting to maintain struts 3 in a resting position, is a cubicfunction of the thickness of strut 3, t_(insertion), and this thicknessmay range from about 30% to about 60% of the thickness of strut 3 duringwithdrawal, T_(withdrawal). Further, as endoscope tip assembly 17 isinserted, no contact is made at C between positive stop 13 and base 4.

Reference is now made to FIG. 21B, which illustrates a cross-sectionview of a strut in a resting position, according to an embodiment of thedisclosure. In a resting position, a contact C exists between base 4 andpositive stop 13 of strut 3.

Reference is now made to FIG. 21C, which illustrates a cross-sectionview of a strut in a withdrawal position, according to an embodiment ofthe disclosure. Upon withdrawal, contact exists at C, between base 4 andpositive stop 13 of strut 3. Further, the resistance to flexing duringwithdrawal, R_(withdrawal), is a cubic function of the total strutthickness during withdrawal, T_(withdrawal), which may be much greaterthan the resistance at insertion, r_(insertion). This withdrawalresistance, R_(withdrawal), may assist in maintaining the invertedumbrella-like shape of struts 3 and webbing 2 upon withdrawal.

Reference is now made to FIG. 22, which illustrates an exemplaryendoscope tip assembly, with pleated webbing that does not extend to theend of the strut, according to an embodiment of the present disclosure.Length 31 represents the distance between the tip of strut 3 and theedge of webbing 2. In some embodiments, length 31 may be 0 mm, asillustrated in FIG. 1. In some embodiments, length 31 may range fromabout 0 mm to about 15 mm. In other embodiments, length 31 may rangefrom about 3 mm to about 10 mm. This length 31, when greater than 0 mm,may facilitate better visualization of the inside of the colon duringthe procedure, as there may be less webbing 2 to obstruct the camera'sview.

Reference is now made to FIG. 23, which illustrates an exemplaryendoscope tip assembly, with pleated webbing that does not extend to theend of the strut, according to an embodiment of the present disclosure.FIG. 23 provides an alternative view of the embodiment illustrated inFIG. 22, where length 31 is a non-zero distance.

Reference is now made to FIG. 24, which illustrates an exemplaryendoscope tip assembly mounted on an endoscope in a resting position,according to an embodiment of the disclosure. Length 31 may be 0 mm, asillustrated in FIG. 6, or, in some embodiments, length 31 may range fromabout 0 mm to about 15 mm, as illustrated in, for example, FIG. 24. Insome embodiments, the radial length of webbing 2 may range from about25% to about 100% of the length of the strut.

Reference is now made to FIG. 25A, which illustrates an exemplaryendoscope tip assembly mounted on an endoscope in a resting position,according to an embodiment of the disclosure. Length 31 may be 0 mm, asillustrated in, for example, FIG. 6, or, in some embodiments, length 31may range from about 0 mm to about 15 mm, as illustrated in, forexample, FIG. 24. In one embodiment, base 4 may contain distal cap 29and shaft sleeve 27. These two pieces may work cooperatively to aid inholding back the lumen such that camera 8 has an unobstructed view. Inone embodiment, such as, for example, FIG. 25A, the width of the distalcap may be consistent along the circumference and may range from about 2mm to about 8 mm. In another embodiment, such as, for example, FIG. 25B,the width of the distal cap 29 may vary along the circumference of thecap, where the width may range from about 2 mm to about 12 mm.

In some embodiments, a method for improved visualization duringendoscopic procedures is provided, wherein an endoscope tip assembly ofthe present disclosure is mounted on the distal end of an endoscopeprior to the procedure.

In some embodiments, a method for improved endoscope stabilizationduring endoscopic procedures is provided, wherein an endoscope tipassembly of the present disclosure is mounted on the distal end of anendoscope prior to the procedure.

In some embodiments, a method for less traumatic endoscopic proceduresis provided, wherein an endoscope tip assembly of the present disclosureis mounted on the distal end of an endoscope prior to the procedure.

While the present disclosure is described herein with reference toillustrative embodiments of endoscope attachments used for particularapplications, such as for performing medical procedures, it should beunderstood that the embodiments described herein are not limitedthereto. For example, scopes and similar devices are often used inindustrial applications, e.g., to inspect and/or repair machinery.Endoscope attachments of the present disclosure may also be used withindustrial scopes in non-medical settings. Those having ordinary skillin the art and access to the teachings provided herein will recognizeadditional modifications, applications, embodiments, and substitution ofequivalents that all fall within the scope of the disclosed embodiments.Accordingly, the disclosed embodiments are not to be considered aslimited by the foregoing or following descriptions.

The many features and advantages of the present disclosure are apparentfrom the detailed specification, and thus it is intended by the appendedclaims to cover all such features and advantages of the presentdisclosure that fall within the true spirit and scope of the presentdisclosure. Further, since numerous modifications and variations willreadily occur to those skilled in the art, it is not desired to limitthe present disclosure to the exact construction and operationillustrated and described and accordingly, all suitable modificationsand equivalents may be resorted to, falling within the scope of thepresent disclosure.

Moreover, those skilled in the art will appreciate that the conceptionupon which this disclosure is based may readily be used as a basis fordesigning other structures, methods, and systems for carrying out theseveral purposes of the present disclosure. Accordingly, the claims arenot to be considered as limited by the foregoing description.

What is claimed is:
 1. An endoscope tip assembly, comprising: aring-shaped base having a substantially cylindrical inner surface thatis dimensioned to receive a distal end of an endoscope; and acollapsible umbrella extending radially out from the base, wherein thecollapsible umbrella includes: a webbing forming a collapsible surface;and a plurality of flexible struts extending along the webbing andconfigured to flex to transition the collapsible umbrella between aninsertion state and a withdrawal state; wherein each of the plurality ofstruts is attached to the inner surface of the base and extend from theinner surface, around an edge of the base, and radiate away from anouter surface of the base terminating at a tip; wherein the webbing iscontinuous and is connected to each of the plurality of struts; andwherein, in the insertion state, the plurality of struts are flexedtoward a direction extending substantially parallel with the outersurface of the base and the tip of each of the plurality of struts ispointed in a proximal direction, and wherein, in the withdrawal state,the plurality of struts are flexed outward away from the outer surfaceof the base and the tip of each of the plurality of struts is pointed ina distal direction substantially parallel to the outer surface of thebase.
 2. The endoscope tip assembly of claim 1, wherein a force requiredto flex the plurality of struts to transition the collapsible umbrellato the insertion state is less than a force required to flex theplurality of struts to transition the collapsible umbrella to thewithdrawal state.
 3. The endoscope tip assembly of claim 1, wherein thetip of each of the plurality of struts is off-axis from an intermediateportion of each of the plurality of struts.
 4. The endoscope tipassembly of claim 1, wherein at least one of the plurality of strutsincludes one or more notches located along a distal-facing surface ofthe strut.
 5. The endoscope tip assembly of claim 1, wherein the base issubstantially rigid.
 6. The endoscope tip assembly of claim 1, whereinthe inner surface of the base includes at least one crush rib projectingfrom the inner surface.
 7. The endoscope tip assembly of claim 1,wherein the webbing is pleated.
 8. The endoscope tip assembly of claim1, wherein the outer surface of the base includes at least one grippingstructure.
 9. The endoscope tip assembly of claim 1, wherein the outersurface of the base includes at least one self-locking window.
 10. Theendoscope tip assembly of claim 1, wherein the base further comprises: ashaft sleeve; a sleeve lock; and a strut support ring.
 11. The endoscopetip assembly of claim 1, wherein the base further comprises: a distalcap; and a shaft sleeve.